LEMSIP MAX ALL IN ONE COLD & FLU

Duration of treatment should be limited to a maximum of 5 days. Patients should consult a doctor or pharmacist if symptoms persist for more than 5 days, or worsen.

Posology Adults, the elderly and children aged 16 years and over:

Two capsules every 4-6 hours, as required. Do not take more than 8 capsules (4 doses) in 24 hours. Do not give to children under 16 years of age.

Elderly Population:

Experience has indicated that normal adult dose is usually appropriate. However, in frail, immobile, elderly subjects or in elderly patients with renal or hepatic impairment, a reduction in the amount of frequency of dosing may be appropriate.

Method of Administration For oral administration. Swallow whole with water. Do not chew.

Adverse events which have been associated with paracetamol and phenylephrine hydrochloride are given below, tabulated by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class Frequency Adverse Events Blood and Lymphatic System Disorders Not known Haemopoietic disorders1● Immune System Disorders Not known Hypersensitivity●■♦ Metabolism and Nutrition Disorders Not known High anion gap metabolic acidosis2 Nervous System Disorders Not known Headache♦ Cardiac Disorders Not known Palpitations♦ Vascular Disorders Not known Hypertension♦ Gastrointestinal Disorders Not known Abdominal discomfort■ , nausea■ , vomiting■ , diarrhoea■ Very rare Cases of serious skin reactions have been reported● Skin and Subcutaneous Tissue Disorders Not known Skin rash● Renal and Urinary Disorders Not known Urinary retention3♦ Description of Selected Adverse Reactions 1 There have been occasional reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 3 Especially in males. ● Paracetamol; ■ Guaifenesin; ♦ Phenylephrine Hydrochloride Reporting of Suspected Adverse Reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Use with caution in patients with Raynaud's phenomenon. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease.

Do not take with any other paracetamol-containing products. 9). Use with caution in patients suffering from porphyria. Respiratory: this product should not be used for persistent or chronic cough such as that occurring with smoking, asthma, chronic bronchitis or emphysema, or for cough associated with excessive phlegm.

A persistent cough may be indicative of a serious condition. If cough persists for more than 5 days, is recurrent, or is accompanied by fever, rash, or persistent headache, a physician should be consulted. g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as an underlying cause of HAGMA in patients with multiple risk factors.

6). Not recommended for concomitant use with a cough suppressant. This medicine contains less than 1 mmol sodium (23mg) per capsule, essentially “sodium free”. Keep out of the sight and reach of children. Do not exceed the stated dose.

If symptoms persist, consult your doctor.

1. Due to the presence of phenylephrine, use of the product is contraindicated in: • Patients with severe coronary heart disease or cardiovascular disorders. • Patients with hypertension. • Patients with hyperthyroidism. • Patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors (MAOIs).

• Patients using other sympathomimetic decongestants concomitantly. • Patients with prostatic enlargement. • Patients with phaeochromocytoma. • Patients with closed-angle glaucoma. • Patients with diabetes mellitus.